The Senior Scientist, Product Lead CMC Regulatory Affairs is a leading expert individual contributor responsible for major portions of complex regulatory submissions and conveying information to clinical development, commercial, and medical affairs teams
Job Summary
The Senior Scientist, Product Lead CMC Regulatory Affairs is a leading expert individual contributor responsible for major portions of complex regulatory submissions and conveying information to clinical development, commercial, and medical affairs teams.
Responsibilities include contributing to global CMC regulatory strategies, participating as the Regulatory CMC Lead on CMC Teams, supporting global regulatory filings, and preparing regulatory dossiers for submission to Health Authorities.
The role requires a BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 6+ years of experience, and offers a base pay range of $109,000.00 - $174,800.00.
Matching Summary
The Senior Scientist, Product Lead CMC Regulatory Affairs is a leading expert individual contributor responsible for major portions of complex regulatory submissions and conveying information to clinical development, commercial, and medical affairs teams.
Salary
Base: $109,000.00 - $174,800.00; Bonus/Equity: Not specified; Benefits: Vacation, Sick time, Holiday pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off
Skills & Requirements
Must-have
CMC regulatory strategies
global regulatory filings
Health Authority interactions
scientific/technical expertise
product development
Nice-to-have
continuous improvement culture
model behavior
cross-functional communication
driving for results
Key Requirements
BS degree with 6+ years experience
MS, Ph.D., or Pharm. D. preferred
Demonstrated ability to communicate regulatory requirements